Product code BXN
- Device name
- Stimulator, Nerve, Battery-Powered
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.2775
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K213049 | STIMPOD NMS450 Nerve Stimulator | Xavant Technology (Pty), Ltd. | 2022-10-16 |
| K162086 | MultiStim ECO | PAJUNK GmbH Medizintechnologie | 2017-01-06 |
| K153045 | SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator | Easy Med Instrument Co., Ltd. | 2016-05-13 |
| K143095 | MiniStim MS-IVB Peripheral Nerve Stimulator | Halyard Health, Inc. | 2015-03-24 |
| K140853 | STIMPOD ST2-3010 NERVE STIMULATOR | Xavant Technology (Pty), Ltd. | 2014-11-06 |
| K121743 | EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN | Sunmed, LLC | 2013-03-28 |
| K111985 | MYOGUIDE SYSTEM MODEL 8008 | Intronix Technologies Corp. | 2011-12-30 |
| K110118 | STIMTRODE SINGLE USE NERVE STIMULATOR | Xavant Technology (Pty), Ltd. | 2011-02-17 |
| K102084 | STIMPOD NMS450 NERVE STIMULATOR | Xavant Technology (Pty), Ltd. | 2010-12-16 |
| K093591 | STIMPOD MODEL NMS-400 NERVE STIMULATOR | Xavant Technology (Pty), Ltd. | 2009-12-03 |
| K091155 | ASCEND | Neurometrix, Inc. | 2009-09-03 |
| K072092 | XPOD/XMAP NERVE STIMULATOR | Xavant Technology (Pty), Ltd. | 2007-11-15 |
| K070134 | MODIFICATION TO STIMUPLEX HNS-12, MODEL 4892098 | Stockert GmbH | 2007-03-22 |
| K062478 | CLAVIS | Medtronic A/S | 2007-02-08 |
| K061983 | STIMUPLEX PEN | Stockert GmbH | 2006-11-21 |
| K061172 | PAJUNK MULTISTIM SENSOR NERVE STIMULATORS | PAJUNK GmbH Medizintechnologie | 2006-10-17 |
| K052313 | STIMUPLEX HNS-12, MODEL 4892098 | Stockert GmbH | 2005-11-17 |
| K021033 | STIMUPLEX-DIG-RC NERVE STIMULATOR | B.Braun Medical, Inc. | 2003-03-21 |
| K011308 | MULTISTIM | Pajunk GmbH | 2001-11-29 |
| K990323 | TE ME NA POLYSTIM NERVE STIMILATOR | Te ME NA S.A.R.L. | 2001-09-28 |
| K003983 | STIMUPLEX HNS-11 | Stockert GmbH | 2001-06-06 |
| K954525 | SENSI-TOUCH EPIDURAL ANESTHESIA FILTER | Sherwood Medical Co. | 1996-01-19 |
| K914164 | VITALMAX 840 SERIES | Pace Tech Medical Monitors, Inc. | 1993-04-09 |
| K913184 | MS-III MINISTIM | Life-Tech Intl., Inc. | 1991-10-07 |
| K905092 | NEUROMUSCULAR TRANSMISSION MONITOR | Utah Medical Products, Inc. | 1991-06-25 |
| K904025 | MYOTRACK, MODEL HH 515 | Myotrack Co. | 1991-03-01 |
| K896368 | MODIFIED AXOSTIM | Singer Medical Products, Inc. | 1989-11-27 |
| K892396 | MINI ACCELOGRAPH NEUROMUSCULAR TRANS. MONITOR | Biometer Intl. A/S | 1989-10-03 |
| K894786 | BIO-INDUSTRY STIM POCHE(R) | The Hader Corp. | 1989-09-29 |
| K893485 | ACCELOGRAPH NEUROMUSCULAR TRANSMISSION MONITOR | Biometer Intl. A/S | 1989-07-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04048223093931 | ExtensionCable 60cm | Pajunk GmbH Medizintechnologie | 2025-01-30 |
| 04048223115794 | MULTISTIM VARIO | Pajunk GmbH Medizintechnologie | 2022-11-21 |
| 04048223115787 | MULTISTIM VARIO | Pajunk GmbH Medizintechnologie | 2021-07-13 |
| 04048223075920 | MULTISTIM SENSOR | Pajunk GmbH Medizintechnologie | 2021-04-02 |
| 00382830049702 | Clavis | NATUS MANUFACTURING LIMITED | 2019-03-12 |
| 06009880396320 | Xavant Technology | XAVANT TECHNOLOGY (PTY) LTD | 2018-01-30 |
| 06009880396313 | Xavant Technology | XAVANT TECHNOLOGY (PTY) LTD | 2018-01-30 |
| 03700339710508 | Temena | Temena GmbH | 2017-12-12 |
| 03700339716395 | Temena | Temena GmbH | 2017-12-12 |
| 06009880396153 | Xavant Technology | XAVANT TECHNOLOGY (PTY) LTD | 2017-04-06 |
| 06009880396146 | Xavant Technology | XAVANT TECHNOLOGY (PTY) LTD | 2017-01-10 |
| 06009880396139 | Xavant Technology | XAVANT TECHNOLOGY (PTY) LTD | 2016-12-07 |
| 04022495101310 | Stimuplex® | B. BRAUN MEDICAL INC. | 2016-09-23 |
| 04022495187826 | Stimuplex® | B. BRAUN MEDICAL INC. | 2016-09-23 |
| 04022495166579 | Stimuplex® | B. BRAUN MEDICAL INC. | 2016-09-23 |
| 04022495101266 | Stimuplex® | B. BRAUN MEDICAL INC. | 2016-09-23 |
| 04022495101211 | Stimuplex® | B. BRAUN MEDICAL INC. | 2016-09-23 |
| 04022495101167 | Stimuplex® | B. BRAUN MEDICAL INC. | 2016-09-23 |
| 10680651134353 | Halyard | Avanos Medical, Inc. | 2016-09-05 |
| 10680651419139 | Halyard | Avanos Medical, Inc. | 2016-09-05 |
| 10680651408713 | Halyard | Avanos Medical, Inc. | 2016-09-05 |
| 10680651400526 | Halyard | Avanos Medical, Inc. | 2016-09-05 |
| 10680651392401 | Halyard | Avanos Medical, Inc. | 2016-09-05 |
| 10680651392333 | Halyard | Avanos Medical, Inc. | 2016-09-05 |
| 10680651392234 | Halyard | Avanos Medical, Inc. | 2016-09-05 |
| 10680651327892 | Halyard | Avanos Medical, Inc. | 2016-09-05 |
| 00613994197580 | Alpine BioMed | Alpine Biomed ApS | 2016-08-24 |
| 05704736002745 | Alpine BioMed | Alpine Biomed ApS | 2016-08-24 |
| 05704736004091 | Alpine BioMed | Alpine Biomed ApS | 2016-08-24 |
| 05704736009546 | Alpine BioMed | Alpine Biomed ApS | 2016-08-24 |